Access to Genetic Information Leveraging Innovative Technology (AGILITY) Study

PROJECT SUMMARY/ABSTRACT The AGILITY (Access to Genetic Information Leveraging Innovative TechnologY) trial will assess layered challenges in realizing precision medicine. This includes a limited genetic counseling workforce to facilitate test decisions, and existing inequities in access to genetic testing. To address these challenges, we will

conduct a Type1 Hybrid Trial that includes three specific aims. The first aim is to take an existing clinical genetics chatbot and tailor it for use in population screening of gene variants that can lead to Hereditary Breast and Ovarian Cancer syndromes, Lynch Syndrome, and Familial Hypercholesterolemia. Due to the

prevalence of the variants and options for taking actions to reduce negative outcomes, 10 genes have been endorsed for population screening by the National Academy of Medicine and the American College of Medical Genetics. To validate the chatbot for the target population, we will use data from interviews with primary care

patients and providers to learn the informational needs to achieve informed test decisions. Once the chatbot is validated, the second aim is to conduct a virtually-implemented randomized controlled trial with primary care patients from a variety of backgrounds. We will test non-inferiority of the chatbot in comparison to

standard genetic counseling. We plan to enroll 2,400 adult participants from five racially, ethnically and socioeconomically diverse primary care clinics at the University of Florida Health System. Patients will be eligible to enroll in the trial if they have no higher risks for the screening conditions. [Those with higher risks

will be offered the opportunity to undergo targeted genetic testing as is standard of care, and followed as a descriptive study arm.] Participants will be randomized to learn about testing via a clinical chatbot or a genetic counselor. Our primary outcome is informed choice about undergoing genetic testing. As such, those who

decline testing are as informative as those who accept. Secondary outcomes include test-related distress, decisional conflict, and testing uptake. Informed choice will be assessed immediately following the decision, after receipt of results for those who accept testing, and 3 and 6 months later for all participants. To ensure

success of the AGILITY Trial, investigators at RTI International will work with the Senior Associate Dean of Research, primary care providers, patients and the community advisory board at the University of Florida Health System to develop recruitment, engagement, and retention strategies. The third aim is to conduct an

implementation assessment of the clinical chatbot as an intervention to optimize genetic counseling without compromising informed decision-making and to facilitate population screening. To do so, we will analyze interviews with participants, genetic counselors, and primary care providers participating in the trial, using

recognized approaches to inform implementation. The AGILITY study will provide evidence in support of workable solutions to address the critical issue of how to provide robust and scalable genetic counseling around predictive genomics in routine clinical care.